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CompletedNCT04312568Updated Mar 18, 2020

Evaluate Safety, Tolerability and Pharmacokinetics of Fadanafil (XZP-5849)in Chinese Healthy Adult Male Subjects

A Phase 1 interventional study of Fadanafil and Placebo in Healthy Subject, sponsored by Sihuan Pharmaceutical Holdings Group Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Sihuan Pharmaceutical Holdings Group Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Aug 2018, registered Mar 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of ascending single dose Fadanafil (XZP-5849)in Chinese healthy adult male subjects. This is the first XZP-5849 clinical study

Read the detailed description

XZP-5849 is a selective phosphodiesterase (PDE5) inhibitor. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study in approximately 66 Chinese healthy adult male subjects. The study consists of 8 cohorts (1 cohort per dose level). Each subject will participate in only one cohort.

02

Conditions studied

  • Healthy Subject

Keywords

  • Healthy Subject
  • PK Study
  • Tolerability
  • Safety Evaluation
03

In context

Lead sponsor

Sihuan Pharmaceutical Holdings Group Ltd. is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male subjects 18-45 years old, inclusive.
  • Body weight ≥50kg and Body Mass Index: 19.0\~25.0 kg/m2, inclusive
  • subjects should be willing to take appropriate contraceptive measures during the period of taking the study drug and within 6 months after discontinuation to avoid pregnancy of their partners.

Exclusion criteria

Exclusion Criteria:

  • Subjects who have a history of clinical significanct drug allergy (especially those who are known or suspected to have a history of allergy to any PDE-5 inhibitor or its components) or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or severe allergic constitution.
  • History of clinically significant ECG abnormality or family history of long QT syndrome (grandparents, parents, brothers and sisters).
  • Subjects with serious systemic diseases, such as respiratory, blood, endocrine, cardiovascular and cerebrovascular diseases or mental disorders.
  • Subjects who have used over-the-counter drugs, health products, herbal medicine or traditional Chinese medicine within 2 weeks before screening, or are taking foods that affect CYP3A4, such as grapefruit or drinks containing grapefruit (except those who occasionally take paracetamol, but the total maximum dose cannot exceed 1g, and the drug is not allowed to take orally within 48 hours before the first administration).
  • Subjects who have used any prescription drugs (especially CYP3A4 inhibitors, nitrates, α receptor blockers, drugs potential to cause QT interval prolongation, etc.) within 4 weeks before screening.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Fadanafil

    8 group: 12.5mg one dose; 25mg one dose; 50mg one dose; 100mg one dose; 200mg one dose; 300mg one dose; 400mg one dose; 500mg one dose

    Drug: Fadanafil

  • Placebo comparator
    Placebo

    8 group: 12.5mg one dose; 25mg one dose; 50mg one dose; 100mg one dose; 200mg one dose; 300mg one dose; 400mg one dose; 500mg one dose

    Drug: Placebo

Interventions

  • DrugFadanafil

    Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose

    Also known as: 5849

  • DrugPlacebo

    Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose

06

What researchers measure

Primary outcomes

  1. Electrocardiogram (ECG)

    To evaluate subject ECG Changing information

    Time frame: Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing.

  2. Pharmacokinetic Parameter AUC(0-24)

    AUC(0-24) of Fadanafile is area under the curve

    Time frame: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 4, 6,8,12, 24,36 hours after Dosing

  3. Blood Pressure and Heart Rate

    To evaluate subject Blood Pressure and Heart Rate Changing information

    Time frame: Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing

07

Study locations

1 site
  • Haiyan Li
    Beijing, Beijing 100076, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04312568
Lead sponsor
Sihuan Pharmaceutical Holdings Group Ltd.
Responsible party
Sponsor
First posted
Mar 18, 2020
Start date
Aug 10, 2018
Primary completion
Dec 7, 2018
Completion
Dec 7, 2018
Last update
Mar 18, 2020

Study contacts

Haiyan Li, Doctor
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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